Clinical Research Coordinator II

Job Description

The Clinical Research Coordinator (Non-RN) plays a pivotal role in managing research studies, trials, and programs. This includes patient screening, assessing eligibility, and coordinating the care and follow-up of volunteers participating in research. The coordinator is responsible for recruiting and consenting research participants, providing exceptional patient-facing interactions, and coordinating biospecimen collection through collaboration with clinical research nursing staff, laboratory teams, and hospital departments to ensure compliance with regulations and protocols.

Responsibilities

• Execute and coordinate the informed consent process for participants in clinical trials and research studies across various locations, which may involve travel or the use of technology.
• Oversee all aspects of research, including patient screening, eligibility assessment, and volunteer participation and follow-up.
• Coordinate the recruitment and consenting of research participants for therapeutic areas served.
• Deliver concierge-level service for all patient-facing interactions during clinical trials and research studies.
• Coordinate or perform biospecimen collection (e.g., blood, tissue) and maintain a HIPAA-protected database linking patient information to biospecimens used in research; conduct patient chart review and data collection.
• Collaborate with Clinical Research nursing staff, Research Services, laboratory teams, hospital departments, and physician offices to ensure regulatory and protocol compliance.
• Work with assistant clinical coordinators to ensure compliant data entry/data mining into registries, patient records, and research-specific database systems.
• Assist Principal Investigators and research staff in developing compliant research protocols and control documents.
• Serve as the study-specific point of contact for participants, investigators, research staff, hospital departments, and external research partners.
• Collaborate with clinical research supervisors and staff to implement standard operating procedures (SOP) for the research division, ensuring compliance with clinical research standards and procedures.
• Maintain sensitivity to cost containment measures by conserving hospital supplies, equipment, and human resources while overseeing project budgets from internal and external funding sources.

Essential Skills

• Ability to work independently in a fast-paced clinical or research environment, managing multiple tasks efficiently and timely.
• Knowledge of HIPAA data protection and patient advocacy, or similar ethical treatment awareness in research.
• Effective communication with research participants, investigators, research staff, and external partners.
• Analytical approach to problem solving, fact analysis, and sound judgment application.
• Ability to accept direction and adapt to the evolving needs of clinical research units.
• Proficiency in Microsoft Office applications, including Word, Excel, Access, Outlook, and Internet skills.